Since the development of the first monoclonal antibodies by Koehler and Milstein in 1974 a lot of effort has been dedicated to the development of antibodies which are appropriate for therapy in humans. The first monoclonal antibodies which became available were developed in mice and rats. In the past ten years an ever growing number of chimeric monoclonal antibodies, humanized monoclonal antibodies or human monoclonal antibodies have reached the market.
Examples of therapeutic monoclonal antibodies (“TmABs”) include abciximab (ReoPro®), adalimumab (Humira®), alemtuzumab (Campath®), basiliximab (Simulect®), bevacizumab (Avastin®), cetuximab (Erbitux®), certolizumab pegol (Cimzia®), daclizumab (Zenapax®), eculizumab (Soliris®), efalizumab (Raptiva®), gemtuzumab (Mylotarg®), ibritumomab tiuxetan (Zevalin®), infliximab (Remicade®), muromonab-CD3 (Orthoclone OKT3®), natalizumab (Tysabri®), omalizumab (Xolair®), palivizumab (Synagis®), panitumumab (Vectibix®), ranibizumab (Lucentis®), rituximab (Rituxan®, MabThera®), trastuzumab (Herceptin®) and tositumomab (Bexxar®).
The various kinds of TmAbs available today include chimeric antibodies, e.g. infliximab (an anti-<TNFα>AB), humanized antibodies, e.g. certolizumab (an anti-<TNFα>AB) and human antibodies, e.g. adalimumab (also an anti-<TNFα>AB) or panitumumab (an anti-<epidermal growth factor receptor>AB). Important investigation criteria of humanized or human TmAbs include the induction of auto-antibodies during treatment, adverse drug reactions (ADRs), bio-availability and antibody clearance, for example. Additionally, data relating to the formation of anti-<TmAB>AB is another investigation criteria which may be used for humanized or human TmAbs.